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Cardiol Therapeutics President and CEO, David Elsley
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Cardiol Therapeutics
Overview
Cardiol Therapeutics (NASDAQ:CRDL,TSX:CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The company’s lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age.
Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
Company Highlights
- Lead Asset in Clinical Development: CardiolRx™, oral drug candidate, in Phase II trials for recurrent pericarditis and acute myocarditis.
- Scientific Rationale: Compelling evidence demonstrating the anti-inflammatory and antifibrotic properties of CardiolRx in myopericardial diseases.
- Innovative Research: Advancing the development of CRD-38, a novel proprietary subcutaneously administered pharmaceutical intended for use in heart failure.
- CRD-38 Positive Study Results: Positive study results demonstrating CRD-38 subcutaneous formulation slowed increases in body weight and heart weight, and prevented increases in key cardiac inflammatory and remodeling markers in a model of heart failure with preserved ejection fraction.
- Broad Exclusivity Protection: Comprehensive intellectual property portfolio. Eligible to pursue FDA orphan drug and EMA orphan medicine designations for CardiolRx.
- Leadership: Experienced management team, board of directors, and scientific advisory board, with extensive expertise in developing therapeutics for inflammatory heart disease.
- Strong Financial Position: Debt-free and well-capitalized to achieve corporate milestones into 2026.
Key Projects
Orphan Drug Program for Recurrent Pericarditis
In November 2023, Cardiol announced that it has exceeded 50 percent of the patient enrollment target for the company-sponsored Phase II open-label MAvERIC-Pilot study investigating the tolerance, safety and efficacy of CardiolRx in patients with recurrent pericarditis. The study will also assess the improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx.
Pericarditis refers to inflammation of the membrane or sac that surrounds the heart (the pericardium) that is most frequently triggered by a viral infection. Recurrent pericarditis is the most common complication following an initial acute episode of pericarditis, and patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Infrequent but life-threatening complications associated with pericarditis include a large accumulation of pericardial fluid, scarring, and constriction of the heart which may limit heart function. The disease is diagnosed in 0.2 percent of all cardiovascular in-hospital admissions and is responsible for 5 percent of emergency room admissions for chest pain in North America and Western Europe. Recurrent pericarditis is the re-appearance of symptoms after a symptom-free period of at least 4 – 6 weeks following an initial acute episode of pericarditis. These recurrences appear in 15 percent to 30 percent of acute cases and usually within 18 months. Furthermore, up to 50 percent of patients with a recurrent episode of pericarditis experience more recurrences. Standard first-line medical therapy consists of non-steroidal anti-inflammatory drugs or aspirin with or without colchicine. Corticosteroids such as prednisone are second-line therapy in patients with continued recurrence and inadequate response to conventional therapy.
The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is generally used as a third-line intervention in patients with a third or fourth recurrence. The number of cases of patients seeking and receiving treatment for recurrent pericarditis annually in the US is estimated at 38,000. Hospitalization due to recurrent pericarditis is often associated with a 5 – 8 day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
The Phase II MAvERIC-Pilot study is expected to enroll 25 patients at clinical centers in the United States that specialize in pericarditis care. The protocol has been designed in collaboration with thought leaders in pericardial disease. The study chairman is Dr. Allan L. Klein, director of the Center of Pericardial Diseases and professor of medicine, at the Heart and Vascular Institute at the Cleveland Clinic. The primary efficacy endpoint is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Additional endpoints during the extension period include the NRS score after 26 weeks of treatment, and changes in inflammatory marker C-reactive protein (CRP), a commonly used clinical marker of inflammation.
“Recurrent pericarditis is a debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity. Results of the MAvERIC-Pilot study will assist in further understanding the therapeutic profile of our lead investigational drug in this condition and inform the design of a pivotal Phase III clinical trial to underpin the potential regulatory approval of CardiolRx, which is also being evaluated in the global ARCHER Phase II trial in patients presenting with acute myocarditis,” said David Elsley, Cardiol Therapeutics’ president and chief executive officer.
In the US, an orphan drug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved. In the US and the European Union, orphan drugs are eligible for accelerated marketing approvals and companies developing orphan drugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the drug developer has sole rights to market the drug.
Recurrent pericarditis is an orphan disease in the United States, thereby making CardiolRx eligible for orphan drug status under the FDA’s Orphan Drug Designation program.
Independent advisors and key investigators comprising six highly distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Monash Victoria Heart Institute, the University of Virginia, and Northwestern University have been established to design, oversee, and guide Cardiol’s Phase II MAvERIC-Pilot study in patients with recurrent pericarditis.
Orphan Drug Program for Acute Myocarditis
In January 2024, Cardiol exceeded 50 percent patient enrollment in ARCHER, the company’s Phase II multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis.
Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Although viral infection is the most common cause of myocarditis, the condition can also result from bacterial infection, commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors.
In a proportion of patients, the inflammation in the heart persists and causes decreased heart function with symptoms and signs of heart failure, and as such treatment is based on standard-of-care recommendations for heart failure. This includes diuretics, ACE inhibitors, angiotensin receptors blockers, beta-blockers, and aldosterone inhibitors. For those with a fulminant presentation, intensive care is often required, with the use of inotropic medications (to increase the force of the heart muscle contraction). Severe cases frequently require ventricular assist devices or extracorporeal oxygenation and may necessitate heart transplantation.
There are no FDA-approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average 7-day length of stay and a 4 – 6 percent risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States.
“The US orphan drug program was successfully utilized to accelerate the first FDA approval of CBD for the treatment of rare forms of pediatric epilepsy, and significant shareholder value was created in the process,” Elsley said. “Given the mortality and significant morbidity risk associated with acute myocarditis, we believe there is a similar opportunity in pursuing an expedited development program of our CardiolRx pharmaceutical CBD formulation for this serious orphan disease which has no accepted standard of care.”
The primary efficacy endpoints of the Phase II ARCHER trial consist of extracellular volume (ECV) and global longitudinal strain (GLS). The secondary efficacy endpoint is left ventricular ejection fraction. Since people with acute myocarditis have impaired heart function, current treatment is based on standard-of-care recommendations for heart failure. This includes diuretics, ACE inhibitors, angiotensin receptors blockers, beta-blockers, and aldosterone inhibitors. For those with a severe and sudden onset presentation, intensive care is often required, with the use of inotropic medications (to increase the force of the heart muscle contraction) and occasionally, heart-lung bypass or ventricular assist devices. There is otherwise no specific treatment for acute myocarditis although some patients have responded to immuno-suppressive therapy (azathioprine) in combination with steroids, but the data are not conclusive enough for this to be the recommended therapy.
An independent clinical steering committee, comprising 10 highly distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, the University of Pittsburgh Medical Center, University Medicine Berlin, Tel Aviv “Sourasky” Medical Center, São Paulo University Medical School, and Pitié Salpêtrière Hospital (Sorbonne University), has been established to design, oversee, and guide Cardiol’s Phase II multi-national ARCHER trial in acute myocarditis.
Cardiol Therapeutics’ Heart Failure Program
Heart failure affects more than 64 million people globally and associated healthcare costs exceed $30 billion annually in the US alone. Heart failure is a chronic, progressive syndrome in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. People with heart failure suffer from shortness of breath, rapid heart rate, edema, reduced exercise capacity, often struggle with simple daily activities and are frequently hospitalized. For many, these symptoms significantly reduce their quality of life. Known causes of heart failure include ischemic heart disease and myocardial infarction (heart attack), hypertension, valvular heart disease, inflammatory diseases of the heart such as myocarditis and cardiomyopathies, anti-cancer therapies, and inherited metabolic diseases.
Heart failure remains a leading cause of morbidity and mortality worldwide and persists as a growing health and economic burden. In the United States alone, 6 million people over the age of 20 are living with heart failure, and this number is projected to increase to more than 8 million by 2030. The total annual cost attributed to heart failure is projected to increase to $69.8 billion by 2030.
Total deaths attributed to heart failure annually in the United States have been reported in the range of 86,000 to more than 300,000, and hospitalizations range from 800,000 to 1.3 million. The five-year mortality rate for those with heart failure has been reported at 52.6 percent overall.
Cardiol is developing CRD-38, a novel proprietary drug formulation designed to deliver cannabidiol by subcutaneous administration. They are undertaking IND-enabling activities to support clinical evaluation of CRD-38 as a therapeutic strategy in heart failure care – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
In 2023, Cardiol announced positive study results from one of its international collaborating research centers indicating how the CRD-38 subcutaneous formulation slowed increases in body weight and heart weight and prevented increases in key cardiac inflammatory and remodeling markers in a model of heart failure with preserved ejection fraction.
Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has also been shown to attenuate several measures of inflammation in models of diabetes, a common comorbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.
Cannabidiol is lipid soluble, virtually insoluble in water, highly sensitive to deactivation in the liver via first-pass metabolism when taken orally and is rapidly cleared from the body. This results in a low overall bioavailability when taken orally. Cardiol’s subcutaneously administered drug formulation is designed to minimize first-pass metabolism, optimize and maintain blood levels of the drug, and target inflammation and increased fibrosis in the heart. Cardiol believes that overcoming the low bioavailability issues associated with cannabidiol will significantly broaden the therapeutic potential of this molecule.
Cardiol Therapeutics’ Key Global Research and Clinical Collaborators
Cardiol is working together with world-class researchers and clinicians at international centers of excellence to leverage their expertise in drug development, experimental execution, inflammation and fibrosis, the treatment of cardiovascular diseases, and clinical trial protocol design. The collaborations provide optimal advice and knowledge platform in pursuit of Cardiol’s purpose: to heal the heart with innovative science.
Management Team
David Elsley – President, Chief Executive Officer, and Director
David Elsley is the founder and CEO of Vasogen and has an MBA degree. Elsley has over 25 years of experience developing, financing, and managing all aspects of corporate development in biotechnology and high-growth organizations. Elsley founded Vasogen, a biotechnology company focused on the research and commercial development of novel therapeutics for the treatment of heart failure and other inflammatory conditions. Elsley assembled a team of management, directors and scientific advisors comprising industry professionals and thought leaders from North America and Europe.
Dr. Andrew Hamer - Chief Medical Officer and Head of Research and Development
Dr. Andrew Hamer has an MBChB degree. He is the former executive director at Amgen, responsible for leading global development of Repatha®. Hamer is the former chief cardiologist at Nelson Hospital, New Zealand. He has over 19 years of experience practicing cardiology and internal medicine.
Chris Waddick - Chief Financial Officer and Director
Chris Waddick has an MBA degree, is a chartered professional accountant, and is a certified management accountant. He has over 30 years of experience in financial and executive roles in the biotechnology and energy industries. Waddick is the former chief financial officer and chief operating officer of Vasogen Inc.
Bernard Lim - Chief Operating Officer
Bernard Lim has over 30 years of experience in the life sciences industry, spanning biotechnology, diagnostics, medical devices, and high-technology companies. He is the founder and CEO of a highly successful drug delivery company that he led from research and development through to commercialization, and facilitated its eventual acquisition by Eli Lily. Lim is a chartered engineer per UK standards and is a member of the Institution of Engineering and Technology.
Andrea B. Parker – Senior Director of Clinical Operations
Dr. Andrea Parker is the former chief scientific officer at Peter Munk Cardiac Center, University Health Network. Parker is a clinical epidemiologist with more than 30 years’ experience in clinical trials design, management, and execution in industry and academic settings.
John A. Geddes – Vice-president, Business Development
John Geddes has over 25 years of experience in the healthcare industry, comprising roles within pharmaceutical, biotechnology, clinical diagnostics, and life science research technology companies. Geddes has an MBA degree and is the former corporate senior director of business development at Luminex Corporation, a DiaSorin Company.
Anne Tomalin - Director of Regulatory and Quality
Anne Tomalin is the founder of CanReg and TPIreg, regulatory firms previously sold to Optum Insight and Innomar Strategies, respectively. Tomalin is an expert in regulatory affairs in Canada, the United States, and Europe.
Blagoya Ristevski - Director of Chemical Engineering and Manufacturing
Blagoja Ristevski graduated with a BSc in chemical engineering and inorganic chemistry from the University of Ss ‘Cyril and Methodius’, Skopje, Macedonia, and pursued postgraduate research on natural biopolymers as drug carriers at King’s College London, UK. For 20 years, he was involved in the research and discovery of active drug molecules, drug delivery technologies, and manufacturing methodologies for finished drug products at several biopharmaceutical companies.
Board of Directors
Guillermo Torre-Amione - Chairman
Guillermo Torre is the president of TecSalud academic medical center and school of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. He is the former director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.
Jennifer M. Chao - Director
Jennifer M. Chao has over 25 years of experience in the biotech and life sciences industries focused primarily on finance and corporate strategy. Chao is managing partner of CoreStrategies Management, a company she founded in 2008 to provide transformational corporate and financial strategies to biotech/life science companies for maximizing core valuation.
Peter Pekos - Director
President and CEO at Dalton Pharma, Peter Pekos has broad experience in research, development, and commercialization of pharmaceuticals, products, and services.
Colin Stott - Director
Colin Stott has over 30 years of experience in pre-clinical and clinical development, with specific expertise in the development of cannabinoid-based medicines. Stott is the chief operating officer of Alterola Biotech Inc. and the former scientific affairs director, international, and research and development operations director for GW Pharmaceuticals, a world leader in the development of cannabinoid therapeutics.
Teri Loxam - Director
Teri Loxam has over 25 years of experience in the pharmaceutical, life sciences and TMT industries with diverse roles spanning strategy, investor relations, finance and communications.. Loxam will be the chief financial officer of Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health.
Michael Willner - Director
Michael Willner has practiced as an attorney and a certified public accountant. He graduated from Emory University Law School as a member of the Emory Law Review. Subsequently, he practiced real estate and corporate law with New York City-based Milbank, Tweed, Hadley & McCloy, one of the nation’s most prominent international law firms. Before his legal career, Willner was employed by the former Arthur Andersen & Company, a national accounting firm, where he practiced in the tax department.
Scientific Advisory Board
Dr. Paul Ridker
Dr. Paul Ridker is director of the Center for Cardiovascular Disease Prevention, a translational research unit at Brigham and Women’s Hospital in Boston (BWH). A cardiovascular medicine specialist, he is also the Eugene Braunwald Professor of Medicine at Harvard School of Medicine (HSM). Ridker received his medical degree from HSM and then completed an internal medicine residency and a cardiology fellowship at BWH. He is board certified in internal medicine. Ridker’s clinical interests include coronary artery disease and the underlying causes and prevention of atherosclerotic disease. He is the author of over 900 peer-reviewed publications and reviews, 64 book chapters, and six textbooks related to cardiovascular medicine.
Dr. Bruce McManus
Dr. Bruce McManus is a professor emeritus of the Department of Pathology and Laboratory Medicine at the University of British Columbia. He has served as CEO of the Center of Excellence for Prevention of Organ Failure (PROOF Center), director of the UBC Center for Heart and Lung Innovation, and scientific director of the Institute of Circulatory and Respiratory Health, CIHR. McManus received BA and MD degrees from the University of Saskatchewan, an MSc from Pennsylvania State University, and a PhD from the University of Toledo. McManus pursued post-doctoral fellowships at the University of California, Santa Barbara in environmental physiology and at the National Heart, Lung, and Blood Institute in Bethesda. McManus served as MD in cardiovascular and pulmonary pathology, and completed residency training at the Peter Bent Brigham Hospital, Harvard University, in Internal Medicine and Pathology.
Dr. Joseph Hill
Dr. Joseph Hill is a professor of internal medicine and molecular biology, chief of cardiology at UT Southwestern Medical Center, in Dallas, and is the director of the Harry S. Moss Heart Center. Hill holds both the James T. Willerson, MD, distinguished chair in cardiovascular diseases, and the Frank M. Ryburn Jr. Chair in Heart Research. He graduated from Duke University with an MD and a PhD in 1987. Hill’s PhD dissertation research was in the field of cardiac ion channel biophysics. He then worked for five years as a postdoctoral fellow at the Institut Pasteur in Paris, studying central and peripheral nicotinic receptors. He next completed an internal medicine internship and residency, as well as a clinical cardiology fellowship, at the Brigham and Women’s Hospital, Harvard Medical School.
PRISM MarketView Features Q&A with President and CEO David Elsley: Cardiol Therapeutics Enters Phase 3 Clinical Trial for CardiolRx Addressing Patients with Recurrent Pericarditis
PRISM MarketView announces the release of an informative interview with Cardiol Therapeutics President and CEO, David Elsley, who discusses the company's lead oral drug, CardiolRx™, which is entering a late-stage Phase III clinical trial, MAVERIC, for patients with recurrent pericarditis who are at high risk for recurrence.
Cardiol Therapeutics is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. Elsley states, "CardiolRx™ is uniquely positioned to address critical gaps in the current treatment options for recurrent pericarditis."
During a discussion with PRISM MarketView, Elsley describes the market opportunity for its lead drug candidate, its key differentiators from other treatments, the recent Phase II MAvERIC-Pilot study results, the company's financial position and key upcoming milestones. "With its potential to be safer, more cost-effective, and disease-modifying, CardiolRx™ could significantly improve the standard of care for the thousands of patients living with recurrent pericarditis," Elsley commented regarding the potential positive impacts and market opportunity for its lead drug candidate.
The full interview can be found at: https://prismmarketview.com/cardiol-therapeutics-nasdaq-crdl-accelerates-late-stage-trial-targeting-1b-recurrent-pericarditis-market-aiming-to-transform-heart-disease-care/
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com .
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Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical Results in Recurrent Pericarditis Presented at the American Heart Association Scientific Sessions 2024
Marked and rapid reductions in both pericarditis pain and inflammation
maintained throughout the 26-week study
Episodes of pericarditis per year substantially reduced
MAvERIC-Pilot results support advancing CardiolRx™ into the Phase II/III MAVERIC-2
and the Phase III MAVERIC-3 clinical trials
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today reported clinical results from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The data showed that the marked improvements in both pericarditis pain and inflammation, previously reported at the 8-week primary endpoint, were maintained throughout the extension period of the 26-week study. The data were included in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic, presented on behalf of the MAvERIC-Pilot investigators. These findings support the initiation of a Phase III trial (MAVERIC-3), designed to assess CardiolRx™ for the treatment of pericarditis patients to prevent recurrence. The MAVERIC-3 trial is expected to run in parallel with the recently announced MAVERIC-2 Phase IIIII trial designed to evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy.
"The data reported today show that patients enrolled in MAvERIC-Pilot, despite the severity of their disease, experienced clinically relevant and rapid reductions in both their pericarditis pain and C-reactive protein levels that were maintained throughout the study. In addition, results demonstrated a substantial reduction in pericarditis episodes per year as compared to the patients' historical event rate prior to the study. Importantly, treatment was shown to be safe and well tolerated in a population who presented with significant disease burden," said Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic. "I look forward to further investigation in the upcoming Phase II/III and Phase III clinical trials."
The MAvERIC-Pilot study enrolled 27 participants (average age 53 years; 67% female) at eight clinical sites across the United States. Average disease duration and the number of pericarditis episodes per year prior to trial entry were 2.7 years and 5.8 events per year, respectively. Baseline pericarditis pain score averaged 5.8 out of 10 and the C-reactive protein ("CRP") level averaged 2.0 mg/dL. In addition to pericarditis chest pain, other manifestations of pericarditis-confirmed diagnosis were pericardial effusion in 21 patients (78%), pericardial rub in 4 (15%), and ST-segment elevation or PR depression in 5 (19%). Stable doses of baseline medications for recurrent pericarditis, in any combination, included colchicine (85% of patients), non-steroidal anti-inflammatory drugs (78%), and corticosteroids (41%). The 26-week study consisted of an 8-week treatment period ("TP") followed by an 18-week extension period ("EP"). In the first 10 days of the TP, CardiolRx™ was added to baseline medications for recurrent pericarditis and up-titrated to 10 mg/kg twice daily, or the maximum tolerated dose. Throughout the TP, patients continued receiving this concomitant therapy but were weaned off baseline medications during the EP to assess pericarditis recurrence while on CardiolRx™ monotherapy.
Summary of results:
- Primary endpoint of patient-reported pericardial pain on an 11-point numerical rating scale from 0-10 showed a mean reduction of 3.7, from 5.8 at baseline (range of 4 to 10) to 2.1 (range of 0 to 6) at week 8.
- Median time to resolution or near resolution of pain (defined as a score of ≤ 2) was rapid and was observed just 5 days following initiation of CardiolRx™ treatment.
- Reduction in pain was maintained throughout the duration of the trial with a mean reduction of 4.3, from 5.8 at baseline to 1.5 at week 26.
- At week 8, 93% (25/27) of patients reported a pain score reduction.
- CRP normalized (≤0.5 mg/dL) at week 8 in 80% (8/10) of the patients with a baseline CRP of ≥1 mg/dL, with a substantial mean reduction of 5.4 mg/dL being observed (5.7mg/dL to 0.3 mg/dL).
- CRP levels for the entire group of patients were reduced from 2.0 mg/dL at baseline to 0.74 and 0.55 at weeks 8 and 26 respectively, with a median time to CRP normalization of 21 days.
- Freedom from recurrence was maintained in 71% (17/24) of patients during the EP when CardiolRx™ was continued and patients were weaned off baseline medications. For those patients experiencing a recurrence the median time to an episode was 7.7 weeks during the EP.
- Number of pericarditis episodes per year was markedly reduced from 5.8 prior to study to 0.9 during the study.
- CardiolRx™ was shown to be safe and well tolerated with eighty-nine percent of patients (24/27) progressing to the EP and overall study drug compliance reported at 95%.
"The compelling results from MAvERIC-Pilot showed that CardiolRx™ resulted in marked and rapid reductions in pericarditis pain and inflammation in patients with a high degree of disease burden as well as a striking decrease in pericarditis episodes per year. The notable impact of CardiolRx™ on these important clinical endpoints demonstrates its potential to offer a more accessible and non-immunosuppressive therapeutic option for tens of thousands of pericarditis patients," said David Elsley, President and CEO of Cardiol Therapeutics. "These results further support advancing our late-stage MAVERIC clinical development program comprising our recently announced Phase II/III MAVERIC-2 trial as well as our planned MAVERIC-3 Phase III trial. Undertaking both trials in parallel provides the exciting opportunity for CardiolRx™ to address the unmet needs of patients in multiple segments that encompass a broad proportion of the pericarditis population."
MAvERIC-PILOT Phase II Study
To be eligible for enrollment in MAvERIC-Pilot, adult patients (≥18 years) were required to present with at least their third pericarditis episode, which included symptomatic pericarditis chest pain with a numerical rating scale ("NRS") pain score ≥4 (on an 11-point numerical rating scale ("NRS") of 0-10), together with either an elevated level of CRP ≥1 mg/dL, a clinical marker of inflammation, or evidence of pericardial inflammation assessed by cardiac imaging with or without elevated CRP. NRS is a validated instrument used to assess patient-reported pericarditis pain. Zero represents 'no pain at all', whereas the upper limit of 10 represents 'the worst pain ever possible'. At baseline eligible patients were permitted to be receiving stable doses of concomitant medications for recurrent pericarditis (non-steroidal anti-inflammatory drugs and/or colchicine and/or oral corticosteroid therapy in any combination).
Pericarditis
Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection. Following that initial episode patients may have multiple recurrences, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's plans to expand the MAVERIC clinical development program and advance CardiolRx™ into the Phase II/III MAVERIC-2 and the Phase III MAVERIC-3 clinical trials, the Company's plans to conduct the MAVERIC-2 and MAVERIC-3 studies in parallel, the MAVERIC-3 Phase III study being designed to assess CardiolRx™ for the treatment of the broader population of pericarditis patients to prevent recurrence, the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/230401
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Cardiol Therapeutics Inc. Added to PRISM Emerging Biotech Index
PRISM MarketView a leading provider of market insights and company news, proudly announces that Cardiol Therapeutics Inc. ( NASDAQ: CRDL, TSX: CRDL ) has been added to the PRISM Emerging Biotech Index, which spotlights companies leading innovation and creating market impact within the biotech sector. Cardiol's focus on anti-inflammatory and anti-fibrotic therapies for heart disease, including its lead candidate CardiolRx™, positions it as a pioneer in addressing major unmet needs in cardiac care.
The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol's MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The MAVERIC-2 trial will evaluate the impact of CardiolRx™ in recurrent pericarditis patients following the cessation of interleukin-1 blocker therapy. MAVERIC-2 is expected to initiate in Q4 2024 at major pericardial disease centers across the United States and Europe, with results anticipated ahead of the company's planned pivotal Phase III MAVERIC-3 trial.
Recurrent pericarditis affects approximately 38,000 patients in the United States annually who have experienced at least one recurrence. The global pericarditis market was valued at $2.44 billion in 2023 and is projected to grow at a CAGR of 5.24% during the forecast period of 2024-2032, reaching $3.87 billion by 2032.
In addition, Cardiol is advancing CRD-38, a proprietary subcutaneously administered therapy for heart failure. Cardiol's broad IP portfolio and regulatory pathway focus, including FDA and European Medicines Agency orphan designations, bolster its strong market positioning. The company is debt-free and well-capitalized to achieve corporate milestones into 2026.
For more information on Cardiol Therapeutics and the PRISM Emerging Biotech Index , visit prismmarketview.com .
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis and heart failure.
Cardiol has received Investigational New Drug Application authorization from the U.S. Food and Drug Administration (FDA) to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath and fatigue and results in physical limitations, reduced quality of life, emergency department visits and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The FDA has granted Orphan Drug Designation to CardiolRx for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com .
About PRISM MarketView
Established in 2020, PRISM MarketView is dedicated to the monitoring and analysis of small-cap stocks in burgeoning sectors. We deliver up-to-the-minute financial market news, provide comprehensive investor tools and foster a dynamic investor community. Central to our offerings are proprietary indexes that observe emerging sectors, including biotech, clean energy, next-generation tech, medical devices and beyond. Visit us at prismmarketview.com and follow us on X.
PRISM MarketView does not provide investment advice.
Disclaimer: This communication was produced by PRISM MarketView (PMV). PMV is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy or a recommendation of any security. PMV may be compensated by respective clients for publicizing information relating to its clients' securities.
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Cardiol Therapeutics to Advance CardiolRx into a Late-Stage Trial in Patients with Recurrent Pericarditis
MAVERIC-2 trial will evaluate the impact of CardiolRx(TM) following cessation of interleukin-1 blocker therapy (rilonacept or anakinra) and is expected to run concurrently with the Company's planned Phase III program.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced plans to expand the MAVERIC clinical development program and advance CardiolRx™ into a late-stage clinical trial ("MAVERIC-2") to evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 ("IL-1") blocker therapy. MAVERIC-2 is expected to be initiated during Q4 at major pericardial disease centres in the United States and Europe and to report results ahead of the Company's planned pivotal Phase III study in recurrent pericarditis.
"MAVERIC-2 provides an exciting opportunity to expand the market potential for CardiolRx through the execution of a cost-effective study and potentially provides a path for an accelerated regulatory approval timeline," said David Elsley, President & CEO of Cardiol Therapeutics. "This important new study, designed in collaboration with an international panel of advisors comprised of experts in pericarditis, will also augment data from our planned Phase III MAVERIC-3 trial by exploring the potential for our lead oral drug candidate to assist the growing number of recurrent pericarditis patients who seek alternative options to chronic use of immunosuppressant biologics."
MAVERIC-2 is a randomized, double-blind, placebo-controlled Phase II/III trial in approximately 110 patients. Patients with stable disease who are receiving IL-1 blocker treatment will be randomly assigned to receive either CardiolRx™ or placebo following cessation of the IL-1 blocker. The primary clinical objective of the trial will be to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis. Other clinical endpoints of interest include time to a new episode of pericarditis recurrence and change in patient-reported pericarditis chest pain score and the inflammatory marker C-reactive protein ("CRP").
IL-1 is a key pro-inflammatory cytokine in the pathophysiology of recurrent pericarditis. It is generated downstream following activation of the NLRP3 inflammasome and amplifies the autoinflammatory response characteristic of the disease. IL-1 blockers (rilonacept or anakinra) target and negate the activity of IL-1, but given their expense and immunosuppressant risks, they are generally prescribed as a third-line intervention in difficult-to-treat patients. There is a growing body of evidence indicating pericarditis recurrence rates are as high as seventy-five percent and onset is rapid following cessation of IL-1 blocker therapy. Currently, many patients who discontinue IL-1 blocker therapy and subsequently suffer a recurrence require rescue treatment with further administration of these biologics, potentially leading to IL-1 blocker dependence.
"CardiolRx™ has been shown experimentally to inhibit assembly and activation of the NLRP3 inflammasome and the subsequent generation of IL-1, and following oral administration has led to marked reductions in pericarditis pain in patients suffering from chronic pericardial disease," said Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "In addition to potentially offering a more accessible and non-immunosuppressive therapy to thousands of patients who are non-responsive or intolerant to current therapies, CardiolRx™ may also have therapeutic potential to prevent recurrences following discontinuation of IL-1 blockers, which would address an unmet need in a growing subset of patients dependant on long-term IL-1 blocker therapy."
The Company previously announced positive topline data from MAvERIC-Pilot investigating CardiolRx™ for recurrent pericarditis which showed a substantial reduction in the primary efficacy endpoint of patient-reported pericarditis pain at the end of the 8-week treatment period ("TP"), as well as normalization of inflammation - as measured by CRP - in 80% of the patients with elevated CRP at baseline. Eighty-nine percent of patients (24/27) progressed from the TP into the now completed extension period ("EP") of the study, defined as the additional 18-week period where background therapy was weaned and patients were followed on monotherapy of CardiolRx™. Full clinical data will be reported in an oral presentation November 18th, 2024, at the American Heart Association Scientific Sessions 2024 and will include freedom from pericarditis recurrence during the 18-week EP, 26-week pericarditis pain score and inflammatory marker levels, and safety and tolerability outcomes. The totality of the MAvERIC-Pilot data will support and further inform the Company's plans related to a second late-stage study called MAVERIC-3, a Phase III pivotal trial designed to assess CardiolRx™ for the treatment of the broader population of pericarditis patients to prevent recurrence.
Pericarditis
Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection. Following that initial episode patients may have multiple recurrences, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary Statement Regarding Forward-Looking Information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's plans to expand the MAVERIC clinical development program and advance CardiolRx™ into a late-stage clinical trial called MAVERIC-2, the Company's expectation to initiate the MAVERIC-2 study during the fourth quarter of 2024 at major pericardial disease centres in the United States and Europe and report results ahead of the Company's planned pivotal Phase III study in recurrent pericarditis, the Company's plans to conduct its Phase III study in recurrent pericarditis concurrently with MAVERIC-2, the Company's intention to report full clinical data from the MAvERIC-Pilot study in an oral presentation at the American Heart Association Scientific Sessions 2024, the Company's expectation that the full clinical data from the MAvERIC-Pilot study presented will include freedom from pericarditis recurrence during the 18-week EP, 26-week pericarditis pain score and inflammatory marker levels and safety and tolerability outcomes, the Company's belief that the MAvERIC-Pilot study data will support and further inform the Company's plans related to a second late-stage study called MAVERIC-3 which the Company intends to be a Phase III pivotal trial designed to assess CardiolRx™ for the treatment of the broader population of pericarditis patients to prevent recurrence, the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/227396
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Cardiol Therapeutics Announces Exercise and Closing of Over-Allotment Option
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that, further to its successfully completed public offering of an aggregate of 8,437,500 Class A common shares of the Company (the "Common Shares") at a price to the public of US$1.60 per Common Share (the "Offering Price") for gross proceeds of US$13.5 million (the "Offering"), Canaccord Genuity has purchased an additional 1,265,625 Common Shares at the Offering Price pursuant to their exercise in full of the over-allotment option (the "Over-Allotment Option"), for additional gross proceeds to the Company of $2,025,000 before deducting the underwriting commissions.
After giving effect to the full exercise of the Over-Allotment Option, Cardiol sold 9,703,125 Common Shares under the Offering, for aggregate gross proceeds of US$15,525,000.
The Company intends to use the net proceeds from the Offering to support the clinical development of CardiolRx for the treatment of recurrent pericarditis and for general and administrative expenses, working capital and other expenses.
Canaccord Genuity acted as the sole bookrunner in connection with the Offering.
The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commissions (the "SEC") on July 16, 2024 (the "Registration Statement"), and the Company's existing Canadian short form base shelf prospectus (the "Base Prospectus") dated July 12, 2024. A preliminary prospectus supplement relating to the Offering was filed with the securities commission in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States, and a final prospectus supplement relating to the Offering (the "Supplement") was filed with the securities commissions in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States. The Supplement and accompanying Base Prospectus contain important detailed information about the Offering.
The Supplement and accompanying Base Prospectus can be found on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Canaccord Genuity LLC, 1 Post Office Square, Suite 3000, Boston, Massachusetts 02109, Attn: Syndicate Department, or by email at prospectus@cgf.com.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the anticipated use of proceeds from the Offering. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/226366
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PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program
- PTC to receive $1.0B in cash at closing -
- PTC is eligible to receive up to $1.9B in development, regulatory and sales milestones -
- PTC to share profits in the U.S. and tiered double-digit royalties on ex-U.S. net sales -
- Novartis will assume global development, manufacturing and commercial responsibilities following completion of placebo-controlled portion of ongoing PIVOT-HD study -
- PTC will host a conference call on Dec. 2, 2024 , at 8:30 am EST -
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the signing of an exclusive global license and collaboration agreement with Novartis Pharmaceuticals Corporation, a subsidiary of Novartis AG (NYSE: NVS), for its PTC518 Huntington's disease program, which includes related molecules. Under the agreement, PTC will receive an upfront payment of $1.0 billion up to $1.9 billion in development, regulatory and sales milestones, a profit share in the U.S., and double-digit tiered royalties on ex-U.S. sales.
"PTC518 is the leading oral disease-modifying therapy in development for Huntington's disease and the economics of this agreement are consistent with the promise of this treatment," said Matthew B. Klein , M.D., Chief Executive Officer, PTC Therapeutics. "This collaboration combines PTC's expertise in developing small molecule splicing therapies with Novartis's expertise in global development and commercialization of neuroscience therapies. We are excited to collaborate with Novartis to accelerate the potential of PTC518 for the hundreds of thousands of HD patients worldwide in need of a therapy designed to be well-tolerated and an effective disease-modifying therapy. PTC will use the proceeds of this transaction to expand our splicing platform as well as to support commercial and development portfolio activities."
"Huntington's Disease is a devastating, fatal, familial disease. This agreement with PTC is intended to bolster our neuroscience pipeline and reflects our strategic focus and commitment to explore new and potentially transformative approaches for neurodegenerative diseases with high unmet needs," said Vas Narasimhan, CEO of Novartis. "We look forward to building on our expertise in neurodegenerative diseases and experience in HD with the intention to advance this potential first in class oral therapy for the HD community."
PTC518 was discovered from PTC's validated splicing platform and is currently being studied in the ongoing Phase 2 PIVOT-HD trial. Interim results reported in June 2024 demonstrated that PTC518 treatment resulted in durable, dose-dependent reduction in blood and cerebrospinal fluid (CSF) mutant Huntingtin protein (HTT) levels as well as early signals of dose-dependent benefit on key clinical measurements at 12 months. 1 Importantly, PTC518 continues to demonstrate a favorable safety and tolerability profile. 1
Novartis will assume responsibility for PTC518's development, manufacturing and commercialization, following the completion of the on-going placebo-controlled portion of PIVOT-HD, which is expected to occur in H1 2025.
The companies will share U.S. profits and losses, on a 40/60 basis (40% PTC and 60% Novartis).
The closing of the transaction is subject to customary closing conditions, including regulatory clearance. The parties anticipate that the agreement will close in the first quarter of 2025.
Conference Call and Webcast Details:
PTC will hold a conference call at 8:30 am EST today to discuss this news. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations . A replay of the call will be available approximately two hours after completion of the call and will be archived on the company's website for 30 days following the call.
About Huntington's Disease
Huntington's disease (HD) is a fatal, hereditary, genetic disorder of the central nervous system. 2 It is caused by a defective gene. This gene produces a protein, called Huntingtin, which is involved in the functioning of the nerve cells in the brain (neurons). When the gene is defective, it produces an abnormal (or mutated) Huntingtin protein that is toxic and causes neuron damage and neuron death. 3 HD usually presents in people who are in their 30s or 40s. Symptoms can present earlier in life, and this is called the Juvenile HD. 3,4 There are also cases of infantile HD, when symptoms develop in children who are younger than 10 years old. 3 While symptoms vary from person to person, the disease primarily affects the brain and results in abnormal movements, difficulties with speech, swallowing and walking, as well as a number of other symptoms including behavioral, cognitive and motor symptoms. 5,6 While there are therapies approved for specific disease symptoms, currently, there is no cure for HD and there are no approved drugs that delay the onset or slow disease progression.
About PTC's Splicing Platform
PTC has pioneered the use of advanced alternative splicing technology to identify small molecules that affect mRNA splicing for the treatment of disease of high unmet need. PTC's validated splicing platform identified the first-ever approved small molecule splicing modifier - Evrysdi ® ( risdiplam ), and PTC has leveraged the extensive learnings from the SMA program to broaden the platform to support discovery programs across numerous therapeutic areas including neurodegenerative disease, oncology and metabolism. PTC has also developed a powerful high-throughput drug discovery platform ( PTSeek ™) that identifies small molecules that modulate pre-mRNA splicing to upregulate or down regulate targeted protein production, accelerating the discovery and early preclinical development process for candidate small molecule splicing agents.
About PTC Therapeutics, Inc.
PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to children and adults living with rare disorders. PTC's ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC's mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC's strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, Instagram, LinkedIn and X.
For More Information:
Investors:
Ellen Cavaleri
+1 (615) 618-6228
ecavaleri@ptcbio.com
Media:
Jeanine Clemente
+1 (908) 912-9406
jclemente@ptcbio.com
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historic fact, are forward-looking statements, including statements with respect to the future expectations, plans and prospects for PTC , including with respect to PTC's right to receive any upfront payment from Novartis ; PTC's right to receive development, regulatory and sales milestones, profit sharing and royalty payments from Novartis ; the continued development of PTC518; future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words, "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward -looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future; the expected benefits and opportunities related to the licensing agreement may not be realized or may take longer to realize than expected due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in development; success in early clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; data for PTC518 may not be sufficient for obtaining regulatory approval; significant business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of PTC's products and product candidates; PTC's scientific approach and general development progress; and the factors discussed in the "Risk Factors" section of PTC's most recent Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.
As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful.
The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.
References:
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- World Health Organization, 2020. 8A01.10 Huntington disease. Available at: https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/2132180242 Accessed October 2021.
- Gatto EM, González Rojas N, Persi G, et al. Clin Parkinsonism Rel Disord 2020;3:100056.
- Tabrizi SJ, Flower MD, Ross CA, et al. Nat Rev Neurol 2020;16(10):529–546.
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SOURCE PTC Therapeutics, Inc.
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Ratio Enters License and Collaboration Agreement with Novartis for SSTR2-targeting Radiotherapeutic Candidate
Ratio to receive upfront, and potential milestones and tiered royalty payments
Ratio Therapeutics Inc. ( Ratio ), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, entered today into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration leverages Ratio's radioligand therapy discovery and development expertise as well as its technology platforms for the development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.
"The team at Ratio is honored and excited to partner with Novartis on the development of a next-generation SSTR2-targeting therapeutic," said Jack Hoppin , Ph.D., Chief Executive Officer of Ratio . "Together, we aim to develop a best-in-class therapy in the fight against SSTR2-expressing tumors."
"Radioligand therapies hold transformative potential for certain forms of cancer, and Novartis is committed to maximizing their impact by continually improving the benefit for patients," said Fiona Marshall , President of Biomedical Research at Novartis. "We are delighted to collaborate with Ratio to advance this RLT candidate and work together to bring forward additional therapeutic options for patients with difficult-to-treat cancer."
Under the terms of the agreement, Ratio will receive combined upfront and potential milestone payments up to $745m , and is eligible to receive tiered royalty payments. Ratio will collaborate with Novartis to drive preclinical activities to research and select an SSTR2-targeting development candidate. Novartis will assume responsibility for all remaining development, manufacturing, and commercialization activities.
The collaboration combines the expertise and strengths of Ratio and Novartis to further elevate the safety and efficacy of radiopharmaceuticals for patient benefit.
Chestnut Partners served as exclusive financial advisor to Ratio for this transaction.
About Ratio Therapeutics
Ratio Therapeutics Inc. is a clinical-stage pharmaceutical company with the mission to accelerate the development of next-generation precision radiopharmaceuticals for solid tumors and transform oncology treatment paradigms. With headquarters and laboratories in Boston, the company currently employs a growing team of multidisciplinary experts with backgrounds in radiopharmaceutical discovery and development. Ratio's proprietary R&D platforms, Trillium™ and Macropa™, enable the development of fit-for-purpose radiopharmaceuticals for therapy and imaging that possess pharmacokinetic modulation, thereby improving drug availability, tumor delivery, and tumor loading. The company is also currently advancing the development of its first FAP-targeted radiotherapeutic with plans to enter clinical trials next year.
Please visit www.ratiotx.com for more information and follow us on Twitter (X) and LinkedIn .
Media Contacts:
Rachelle Babb , Ph.D.
Russo Partners, LLC
rachelle.babb@russopartnersllc.com
+1 (929) 325-7559
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SOURCE Ratio Therapeutics Inc.
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